MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for PRESTIGE ATRAUMATIC GRASPER 8360-10 manufactured by Aesculap, Inc..
[182729369]
Instrument broke during surgery. X-ray confirmed no retained foreign objects. Grasper part of the device bent backwards - pulled out of trocar - would not fit back thru the trocar. Pulled everything out together, then it broke. Bent inside of the patient. No harm to the patient one instrument is an aesculap 8360-10 surgical laparoscopic prestige grasper.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9810690 |
| MDR Report Key | 9810690 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-27 |
| Report Date | 2020-03-02 |
| Date Reported to FDA | 2020-03-02 |
| Date Reported to Mfgr | 2020-03-10 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESTIGE ATRAUMATIC GRASPER |
| Generic Name | LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC |
| Product Code | NWV |
| Date Received | 2020-03-10 |
| Model Number | 8360-10 |
| Catalog Number | 8360-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |